High-dose Inhaled NO Therapy for the Prevention of Nosocomial Pneumonia After Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Incidence of nosocomial pneumonia (percent)
研究概览
简要总结
The primary aim of this single-center, prospective, randomized, controlled, pilot study is to test the hypothesis that inhalation of NO 200 ppm prevents the development of nosocomial pneumonia in patients at risk after cardiac surgery with CPB. The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk National Research Medical Center for elective surgery with CPB.
详细描述
NOSOCOMIAL PNEUMONIA AFTER CARDIAC SURGERY WITH CADIOPULMONARY BYPASS. Nosocomial pneumonia (NP) is one of the most common complications of cardiac surgery with cardiopulmonary bypass (CPB), its frequency according to various sources ranges from 2 to 10% . This complication is accompanied by higher mortality (0.7-4% in patients without pneumonia vs. 25.1-28.2% in patients with pneumonia) , prolonged hospital stay and increased economic costs.
In the retrospective analysis of medical histories of patients operated on CPB for 2020, 2021 and 2022, 3 main risk factors for the development of NP in the postoperative period were identified: time of CPB ≥ 96 minutes, duration of mechanical ventilation ≥ 14 hours, and the presence of atrial fibrillation (AF) before surgery.
STUDY NATURE In relation to medical procedures, this study is observational. The examination and treatment of patients will be carried out in accordance with the approved standards of medical care for the respective diseases. In this study, no experimental or unregistered (not approved for use) medical or diagnostic procedures on the territory of the Russian Federation will be carried out.
STUDY TYPE Single-center, prospective, double-blind, randomized, controlled, parallel group study.
STUDY OBJECTIVES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgery with CPB at current hospitalization.
- •Age > 18 years.
- •Signed informed consent.
- •The presence of at least one risk factor for the development of postoperative NP (CPB time ≥ 96 minutes and/or mechanical ventilation ≥ 14 hours and/or atrial fibrillation before surgery).
排除标准
- •Emergency surgery.
- •Acute coronary syndrome 30 days before surgery.
- •Surgery for active infective endocarditis requiring antibiotic therapy.
- •Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, etc.).
- •Taking antibacterial drugs for 14 days preceding surgery.
- •Other complications of the postoperative period (pneumothorax requiring pleural drainage, perioperative myocardial infarction accompanied by pulmonary edema, shock of any etiology during the current hospitalization).
- •Potentially dialysis-dependent stage 2 and higher acute kidney injury (according to KDIGO) in the early postoperative period (the criteria for potentially dialysis-dependent acute kidney injury will include patients with stage 2 acute kidney injury and: oliguria against the background of normo-hypervolemia and resistance to loop diuretics and/or oliguria against the background of conducting infusion therapy due to hypovolemia and resistance to loop diuretics).
- •Continued mechanical ventilation.
- •Presence of tracheostomy.
- •Patient's participation in another clinical trial at the time of screening or within the previous 3 months.
- •Concomitant pulmonary disease with the need for respiratory support before surgery.
- •History of malignancy or other irreversible diseases/conditions with a 6-month mortality rate >50%.
- •Presence of HIV infection.
研究组 & 干预措施
Control group
Oxygen-air mixture without NO after extubation within 5 days after surgery 2 times a day for 30 min
干预措施: Sham treatment (Drug)
200 ppm
NO will be supplemented at 200-ppm concentration after extubation within 5 days after surgery 2 times a day for 30 min
干预措施: 200- ppm NO (Drug)
结局指标
主要结局
Incidence of nosocomial pneumonia (percent)
时间窗: From the date of randomization until the date of discharge from hospital (from 2 to 4 weeks)
Differences between groups in the incidence of nosocomial pneumonia development (percent).
次要结局
- Level of fever (˚C)(7 days)
- Level of leukocytes (counts)(7 days)
- Incidence of sepsis and septic shock (percent)(7 days)
- Level of C-reactive protein (mg/L)(7 days)
- S/F index (ratio)(7 days)
- Incidence of extrapulmonary complications (percent)(7 days)